Neuro Imaging and Multimodal Alzheimer's Disease

NCT ID: NCT02839187

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-05-31

Brief Summary

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The present study aimed at measuring cerebral changes in Alzheimer Disease (AD) patients, who responded to strict physiological criteria typical of AD pathology. The objective of the present study was to identify the earliest alterations in cerebral connections that could contribute to the initial episodic memory impairment.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients with Alzheimer Disease

Patients will have Neuroimaging by Florbetapir (AV-45)-positron emission tomography

Group Type EXPERIMENTAL

Neuroimaging

Intervention Type RADIATION

AV45-positron emission tomography

Controls patients

Controls will have neuroimaging by AV45-positron emission tomography

Group Type ACTIVE_COMPARATOR

Neuroimaging

Intervention Type RADIATION

AV45-positron emission tomography

Interventions

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Neuroimaging

AV45-positron emission tomography

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

For all subjects :

* Capacities visual, auditory (authorized devices) and oral or written expression sufficient for the proper performance of tests
* Obtain informed written consent of the subject

Patients with AD :

* Outpatient accompanied by a "helping"
* No parenchymal lesions allowing isolation explain the symptoms on brain MRI (T1 and T2) carried more than 6 months prior to enrollment in the study. Patients with more than three hyperintense white matter or visible lacunar infarction or T2 FLAIR will not be included in the study.
* probable Alzheimer's disease diagnosis par with international standards
* Illness in a mild stage (CDR 1, 24 ≥ Mini-Mental State Examination (MMSE)\> 18)
* activity of daily living (ADL) 4 items\> 1/4

Patients with Alzheimer's disease at a pre-dementia stage:

* Alzheimer's Diagnosis pre-dementia based on the search criteria
* Illness in a mild stage (CDR 0.5, 30 ≥ MMSE ≥ 25)
* ADL items ≤ 4 1/4

Control subjects :

* 30 ≥ MMSE ≥ 27
* perfect autonomy in daily living (IADL = 0, CDR = 0)
* Neuropsychological evaluation not highlighting of impaired cognitive performance with focus on memory performance
* No parenchymal lesions on brain MRI.
* Lack of family history (first degree) of Alzheimer's disease

Exclusion Criteria

* Subjects with a contra-indication to MRI (carrying a pacemaker or cardiac defibrillator, implanted a material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid artery , holders of orthopedic implants, claustrophobia)
* Subjects with clinically significant gastrointestinal, renal, hepatic, endocrine, or cardiovascular
* Subjects with a psychiatric disorder or progressive neurological
* French Language level insufficient to be appropriately involved in neurophysiological evaluation
* less than 5 years Education (insufficient understanding level to participate in the study)
* Administrative problems: unable to give informed about information, not covered by a social security system
* Hypersensitivity to the active substance or to any of the excipients
* unbalanced diabetes mellitus
* Subjects treated by a non-steroidal anti-inflammatory
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PARIENTE Jérémie, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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Nemmi F, Saint-Aubert L, Adel D, Salabert AS, Pariente J, Barbeau EJ, Payoux P, Peran P. Insight on AV-45 binding in white and grey matter from histogram analysis: a study on early Alzheimer's disease patients and healthy subjects. Eur J Nucl Med Mol Imaging. 2014 Jul;41(7):1408-18. doi: 10.1007/s00259-014-2728-4. Epub 2014 Feb 27.

Reference Type RESULT
PMID: 24573658 (View on PubMed)

Saint-Aubert L, Nemmi F, Peran P, Barbeau EJ, Payoux P, Chollet F, Pariente J. Comparison between PET template-based method and MRI-based method for cortical quantification of florbetapir (AV-45) uptake in vivo. Eur J Nucl Med Mol Imaging. 2014 May;41(5):836-43. doi: 10.1007/s00259-013-2656-8. Epub 2013 Dec 19.

Reference Type RESULT
PMID: 24435769 (View on PubMed)

Saint-Aubert L, Barbeau EJ, Peran P, Nemmi F, Vervueren C, Mirabel H, Payoux P, Hitzel A, Bonneville F, Gramada R, Tafani M, Vincent C, Puel M, Dechaumont S, Chollet F, Pariente J. Cortical florbetapir-PET amyloid load in prodromal Alzheimer's disease patients. EJNMMI Res. 2013 Jun 3;3(1):43. doi: 10.1186/2191-219X-3-43.

Reference Type RESULT
PMID: 23731789 (View on PubMed)

Other Identifiers

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07 306 02

Identifier Type: -

Identifier Source: org_study_id

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